Combining all the Analyse-it statistical analysis, method validation, and statistical process control tools in a single package.
Analyse-it is developed for and is in use at thousands of ISO/IEC 17025 accredited testing and calibration laboratories, ISO 15189 accredited medical laboratories, CLIA ’88 regulated medical laboratories, and IVD manufacturers for development, support, product labeling and FDA 510(k) submissions.
The latest Clinical and Laboratory Standards Institute (CLSI) method validation protocols are recognized by the College of American Pathologists (CAP), The Joint Commission, and the US Food and Drug Administration (FDA).
It’s essential to ensure the performance characteristics (precision, trueness, linearity, interferences, detection capability) of a measurement procedure meet the requirements for intended use. Manufacturers (IVD companies) must establish performance during product development to feedback into the development process, for FDA 510k submissions and product marketing, and to support customers in the field. Laboratories must verify they can achieve the manufacturer’s claimed performance during implementation of a new measurement system, during regulatory inspections (under the CLIA ’88 act), and as part of proficiency testing (PT) schemes. Measurement systems analysis (MSA) lets you determine all these important performance characteristics in one analysis.
Rated best ROC curve software in Clinical Chemistry March 2003 vol. 49 no. 3 pg. 433-439, Analyse-it lets you establish and compare the ability of a diagnostic test to correctly diagnose patients. Explore how the test differentiates between positive and negative cases and explore optimum decision thresholds factoring in the costs of misdiagnosis.
When introducing a new measurement procedure you want to see how it stacks-up against your existing procedure or evaluate its performance against the gold-standard. Bland-Altman lets you see the agreement between methods and what effect the differences between methods might have on clinical interpretation. More advanced procedures like Deming regression and Passing-Bablok tell you the bias between methods, how medical decision points may be affected, and let you test if bias meets performance requirements.
Reference intervals are essential for clinicians to interpret results and make a diagnosis. As a laboratory it’s your job to provide normal reference ranges they can rely on. With the widest range of methods available in any software package, the ability to partition the intervals by factors such as sex, age, ethnicity, Analyse-it makes it easy to establish reference ranges or transfer them to a new measurement procedure.
Gain insight and improve process performance with Shewhart variable and attribute, CUSUM, and moving average control charts (EWMA & UWMA). Apply WECO, Nelson and Montgomery rules to help identify possible out of control situations. Use stratification to gain further insight into problems and spot trends and patterns. And when you’ve implemented improvements, or made other changes, phases let you track performance before and after so you can ensure improvements have been made and are sustained.
Pareto analysis helps you quickly identify commonly occurring defects so you can focus your efforts making improvements that will reap the most rewards. Stratification lets you break-down defects so you can identify contributing factors, such as an operator that is influencing defect rates, or look at defects before and after process improvements to ensure the changes are reducing defects.
Determine process capability indices for process performance to ensure you deliver products that meet your customers’ requirements. A happy customer means fewer rejected goods and service complaints, improving your business and lowering costs.